510(k) · Cleared
ClearedDornier Medilas H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornier Surgical Products, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 17, 1998 as substantially equivalent to K964760 (Dornier Medtech America, Inc., 1997) after a 63-day review. Its family tree reaches back 1 generation to 1997. 348 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964760 (1997). 348 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK964760 Dornier Medilas Fiber Tome LaserDornier Medtech America, Inc. · 1997
- This deviceK981718 Dornier Medilas HDornier Surgical Products, Inc. · 1998
- Descendant · cites it directly · 346 of its ownK983963 Dornier Medila HDornier Medtech America, Inc. · 1998
- Descendant · 2 generations on · 344 of its ownK984591 Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999
- Descendant · 3 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- Descendant · 4 generations on · 136 of its ownK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
- Descendant · 4 generations on · 136 of its ownK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
Showing 5 of 348 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 348 · See all- K983963Dornier Medila HDornier Medtech America, Inc. · 1998 · cites it directly346descendants
- K984591Dornier Medilas H/2Dornier Surgical Products, Inc. · 1999 · 2 generations on344descendants
- K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 3 generations on342descendants
- K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009 · 4 generations on136descendants
- K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009 · 4 generations on136descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964760 | Dornier Medilas Fiber Tome Laser | Dornier Medtech America, Inc. | 1997 | — |
| 0 (this device) | K981718 | Dornier Medilas H | Dornier Surgical Products, Inc. | 1998 | — |
| +1 | K983963 | Dornier Medila H | Dornier Medtech America, Inc. | 1998 | — |
| +2 | K984591 | Dornier Medilas H/2 | Dornier Surgical Products, Inc. | 1999 | — |
| +3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| +4 | K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers | Patholase, Inc. | 2009 | — |
| +4 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 13 | 0 |
| 2012 | 18 | 0 |
| 2013 | 21 | 0 |
| 2014 | 15 | 0 |
| 2015 | 15 | 0 |
| 2016 | 26 | 0 |
| 2017 | 16 | 0 |
| 2018 | 15 | 0 |
| 2019 | 11 | 0 |
| 2020 | 20 | 0 |
| 2021 | 15 | 0 |
| 2022 | 19 | 0 |
| 2023 | 20 | 0 |
| 2024 | 20 | 0 |
| 2025 | 32 | 0 |
| 2026 | 25 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964760 | Dornier Medilas Fiber Tome LaserSummary page 2…lled internal closed circuit water system. The cooling system in the Medilas H is identical to the system included in the previously cleared 510(k) for the Medilas 5100 (K964760). In order to conduct away the 60 257 Eagi17(8 heat produced by the laser pump lamp, the cooling circuit dissip… | 1997 |
| * | — | Coherent’s VersaPulse 2.1 Named without a submission number |
What descends from it? (348)
See all 3483 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Dornier Medilas H Laser, is intended to be used for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, colonoscopes, or for open surgery for contact or noncontact surgery with or without hand pieces for use in coagulation, incision/exiciions, ablation and vaporization of soft tissue. The laser is indicated for use in medicine and surgery, in the following specialties: Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, and General Surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981718: Dornier Medilas H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026